NCT02937220

Brief Summary

The aim of this study is to evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 16, 2016

Last Update Submit

October 17, 2016

Conditions

Single Tooth Dental Implant

Outcome Measures

Primary Outcomes (1)

  • P.E.S.

    Pink aesthetic scoring system for soft tissue aesthetics

    1 year

Secondary Outcomes (1)

  • crestal bone resorption

    1 year

Study Arms (2)

Monolithic zirconia crowns

EXPERIMENTAL

New crown material to restore dental implants

Procedure: monolithic zirconia crown

metal ceramic crowns

ACTIVE COMPARATOR

conventional crown material for restoring dental implants

Procedure: metal ceramic crown

Interventions

monolithic zirconia crownPROCEDURE

New crown material used as final restoration for dental implants

Monolithic zirconia crowns
metal ceramic crownPROCEDURE

Conventional crown material used as final restoration for dental implants

metal ceramic crowns

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients above 18 years old.
  • Patients able to read and sign the informed consent document. 3. Medically free patients or with controlled systemic disease.
  • \. Patients with good bone quality and quantity evaluated using C.B.C.T. 5. Patients willing to return for follow-up examinations and evaluation. 6. Patients having single missing recently extracted premolar tooth.

You may not qualify if:

  • Young patients in growth stage.
  • Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
  • Pregnant women to avoid any complication that may occur in dental office.
  • Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
  • Psychiatric problems or unrealistic expectations.
  • Multiple adjacent missing teeth.
  • Patients with bad oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 16, 2016

First Posted

October 18, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 18, 2016

Record last verified: 2016-10